Adapted physical activity program for women during active breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional project compares a standardized adapted physical activity (APA) program to conventional management based on simple physical activity recommendations for women receiving surgery, chemotherapy, radiotherapy, and/or hormone therapy. Eligible participants are women medically able to take part in exercise who are treated at the coordinating center and will be assigned to the APA program or to conventional management. The study will collect patient-reported quality of life, symptoms and treatment side effects, and health care resource use to quantify costs associated with each approach. Health economic analyses will compare costs and effectiveness to determine the value of offering a structured APA program during the active treatment phase.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* women with breast cancer
* any type of breast cancer, all grades, all stages
* during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy

Exclusion Criteria:

* World Health Organization (WHO) 4
* Unstable angina
* Uncontrolled Atrial fibrillation
* Uncontrolled high blood pressure
* Recent myocardial infarction or myocarditis or pericarditis or thromboembolic disease (less than 3 weeks)
* Aortic stenosis or valve disease to operate
* Cardiac or respiratory failure, with dyspnea at rest
* Symptomatic anemia, thrombocytopenia
* Lytic or painful bone metastases, Severe osteoporosis
* Severe infectious syndrome,
* Surgery in the last 3 weeks
* Extreme fatigue, sharp pain, dizziness, disturbance of consciousness, severe undernutrition
* Contraindication to the practice of an adapted physical activity programme
* Currently involved or exclusion period of a interventional study or adapted Physical Activity program
* Patient with protective measures (guardianship, curators, and deprivation of liberty).
* Pregnancy or breastfeeding
* Patient with severe functional limitations

Where it's running

• Marie-Eve Rougé-Bugat
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Marie-Eve Rougé-Bugat, MD — University Toulouse
• Study coordinator: Marie-Eve Rougé-Bugat, MD
• Email: marieeve.rouge-bugat@dumg-toulouse.fr
• Phone: 5 61 80 01 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.